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MHRA to introduce new UK clinical trials framework

The changes will aim to make it easier to gain approval and to run clinical trials in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will be introducing a series of measures aimed at streamlining clinical trials approvals in the UK. The changes, which represent the biggest overhaul in UK clinical trials regulation in over 20 years, include a legislative requirement to publicly register clinical trials and share summary results with research participants, as well as guidance to help researchers recruit a diverse cohort of participants. A timeline for completion of an application review within a maximum of 30 days will also be implemented by the MHRA, with a maximum of ten days for a decision to be granted once the regulator has received any final information. Marc Bailey, MHRA chief science and innovation officer, said: “Our world-first COVID-19 approvals showed how ...
- Source: drugdu
- 129
- March 23, 2023
FDA Grants Breakthrough Therapy Designation to Pfizer’s Investigational Alzheimer’s Disease Treatment

Pfizer, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational treatment for Alzheimer’s disease, called PF-05217917. This designation is intended to accelerate the development and review of promising drugs that have the potential to address serious or life-threatening conditions. Alzheimer’s disease is a progressive brain disorder that affects millions of people worldwide, causing memory loss and other cognitive impairments. There are currently no approved treatments that can slow or stop the progression of the disease. Pfizer’s PF-05217917 is an antibody that targets the tau protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. The FDA’s decision to grant Breakthrough Therapy designation to PF-05217917 was based on the results of a Phase 2 clinical trial that involved patients with mild to moderate Alzheimer’s disease. The trial showed that ...
- Source: drugdu
- 252
- March 22, 2023
FDA Approves New Drug to Treat Migraine

The U.S. Food and Drug Administration (FDA) has approved a new drug, called Rizaport, for the treatment of acute migraine in adults. Rizaport is a fast-dissolving oral tablet that contains the active ingredient rizatriptan, which belongs to a class of drugs called triptans. Migraine is a neurological condition that affects approximately 39 million people in the United States. It is characterized by recurrent episodes of moderate to severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. Triptans are a commonly used class of drugs for the treatment of acute migraine, but they are not effective for all patients and may cause side effects such as dizziness and fatigue. Rizaport, developed by Intec Pharma, offers a new option for the treatment of acute migraine. It is designed to dissolve rapidly on the tongue, allowing for faster onset of action compared to traditional tablet formulations. In ...
- Source: drugdu
- 128
- March 22, 2023
Novartis Receives FDA Approval for New Heart Failure Drug

Novartis, a global pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its new heart failure drug, called Entresto XR. This approval expands the use of the company’s existing heart failure drug, Entresto, by making it available in an extended-release form. Heart failure is a chronic condition in which the heart is unable to pump enough blood to meet the body’s needs. It affects millions of people worldwide and is a leading cause of hospitalization and death. Entresto XR is a once-daily tablet that combines two medications, sacubitril and valsartan, to reduce the strain on the heart and improve its ability to pump blood. The FDA’s approval of Entresto XR was based on the results of a clinical trial that involved over 5,000 patients with heart failure. The trial showed that Entresto XR was superior to the standard of care, enalapril, in ...
- Source: drugdu
- 252
- March 22, 2023
FDA Approves New Treatment for Rare Genetic Disorder

The U.S. Food and Drug Administration (FDA) has recently approved a new treatment for a rare genetic disorder called hereditary angioedema (HAE). The treatment, called Berinert, is manufactured by CSL Behring and is the first and only therapy approved for the treatment of acute attacks of HAE in pediatric patients. HAE is a rare genetic disorder that affects about 1 in 10,000 to 1 in 50,000 people worldwide. It is characterized by recurrent episodes of swelling, or edema, in various parts of the body including the hands, feet, face, and airways. These attacks can be severe and potentially life-threatening, especially when the swelling occurs in the airways, which can lead to difficulty breathing and asphyxiation. Berinert is a human plasma-derived C1 esterase inhibitor (C1-INH) that works by replacing the deficient or malfunctioning C1-INH protein in patients with HAE. The treatment is administered through intravenous infusion and can ...
- Source: drugdu
- 123
- March 22, 2023
Ukraine to clinch first IMF loan to nation at war

The International Monetary Fund (IMF) says it has reached an agreement with Ukraine on funding worth $15.6bn (£12.8bn). The organisation’s first loan to a country at war is expected to be approved in the coming weeks. It would also be one of the largest financing packages Ukraine has received since Russia’s invasion. The IMF recently changed a rule to allow loans to countries facing “exceptionally high uncertainty”. “Russia’s invasion of Ukraine continues to have a devastating impact on the economy: activity contracted by 30 percent in 2022, a large share of the capital stock has been destroyed, and poverty levels have climbed,” IMF official Gavin Gray said in a statement. “The programme has been designed in line with the new fund’s policy on lending under exceptionally high uncertainty, and strong financing assurances are expected from donors, including the G7 and EU.” Mr Gray also ...
- Source: drugdu
- 257
- March 22, 2023
Chile detects new bird flu outbreak in industrial facility

Bird flu outbreak forced Chile to suspend certification as free of avian influenza. Chilean authorities on Tuesday reported a new bird flu outbreak at an industrial facility in the Maule region in the southern part of the country. “This finding was made after a complaint made to the Maule SAG (agrigulture and livestock agency) about an increase in mortality on the farm of around 70 birds and another 60 that were symptomatic of the virus,” the Ministry of Agriculture said in a statement. The statement said the birds, which were egg producers, in the industrial plant were sacrificed. The center had between 4,000 to 5,000 specimens. The first bird flu outbreak in an industrial setting was detected in mid-March, forcing the country to suspend its certification as a country free of highly pathogenic avian influenza for 30 days. CHILE CULLS WHOPPING 40,000 POULTRY AFTER DETECTING 1ST ...
- Source: drugdu
- 112
- March 22, 2023
Google’s rival to ChatGPT launches for over-18s

Google has started rolling out its AI chatbot Bard, but it is only available to certain users and they have to be over the age of 18. Unlike its viral rival ChatGPT, it can access up-to-date information from the internet and has a “Google it” button which accesses search. It also namechecks its sources for facts, such as Wikipedia. But Google warned Bard would have “limitations” and said it might share misinformation and display bias. This is because it “learns” from real-world information, in which those biases currently exist – meaning it is possible for stereotypes and false information to show up in its responses. How do chatbots work? AI chatbots are programmed to answer questions online using natural, human-like language. They can write anything from speeches and marketing copy to computer code and student essays. When ChatGPT launched in November 2022, it had more than one million users within ...
- Source: drugdu
- 141
- March 22, 2023
Moderna expects to price its COVID vaccine at about $130 in the US

March 20 (Reuters) – Moderna Inc (MRNA.O) expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. “There are different customers negotiating different prices right now, which is why it’s a little bit complicated,” Hoge said ahead of a Congressional hearing run by Democratic U.S. Senator Bernie Sanders on Moderna’s pricing plans. Moderna previously said it was considering pricing its COVID vaccine in a range of $110 to $130 per dose in the United States, similar to the range Pfizer Inc (PFE.N) said in October it was considering for its rival COVID shots sold in partnership with BioNTech (22UAy.DE). Hoge said the government’s Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. That there were two to three times more hospitalizations and deaths ...
- Source: drugdu
- 137
- March 22, 2023
Roche teams up with Lilly to validate Alzheimer’s blood test

March 22 (Reuters) – Roche (ROG.S) and Eli Lilly and Co (LLY.N) are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval. The effort, unveiled in a statement on Wednesday, comes as Lilly as well as Eisai (4523.T) and Biogen (BIIB.O) are gearing up to sell drugs aimed at slowing the advance of the mind-robbing illness, but their use will require a diagnosis at earlier disease stages than is the norm today. Roche Holding AG would recruit several hundred volunteers with early signs of dementia over the next 18 to 24 months with trial data potentially ready for a U.S. regulatory filing in 2025, Bruce Jordan, leader of Personalized Healthcare Solutions at Roche Diagnostics, told Reuters. The U.S. Food and Drug Administration has asked Roche to recruit a significant number of patients at primary care facilities ...
- Source: drugdu
- 144
- March 22, 2023

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